MXZ · Class II · 21 CFR 864.1860

FDA Product Code MXZ: Immunohistochemistry Assay, Antibody, Progesterone Receptor

Leading manufacturers include Dako North America, Inc., Leica Biosystems Newcastle, Limited and Dakocytomation California, Inc..

13
Total
13
Cleared
141d
Avg days
1999
Since

FDA 510(k) Cleared Immunohistochemistry Assay, Antibody, Progesterone Receptor Devices (Product Code MXZ)

13 devices
1–13 of 13
Cleared Mar 06, 2020
BOND Ready-to-Use Primary Antibody Progesterone Receptor (16), Novocastra Liquid Mouse Monoclonal Antibody Progesterone Receptor Clone 16 (Concentrated Liquid Antibody Format).
K193393
Leica Biosystems Newcastle, Ltd.
Pathology · 91d
Cleared Dec 07, 2018
BOND Ready-to-Use (RTU) Primary Antibody Progesterone Receptor (16) , Novocastra Concentrated Liquid Mouse Monoclonal Antibody
K183102
Leica Biosystems Newcastle, Limited
Pathology · 30d
Cleared Dec 21, 2017
FLEX Monoclonal Mouse Anti-Human Progesterone Receptor, Clone PgR 1294, Ready-to-Use (Dako Omnis)
K170005
Dako Denmark A/S
Pathology · 352d
Cleared Jul 21, 2017
BOND Ready-to-Use (RTU) Primary Antibody Progesterone Receptor (16), Novocastra Liquid Mouse Monoclonal Antibody Progesterone Receptor Clone 16
K171753
Leica Biosystems Newcastle, Limited
Pathology · 39d
Cleared May 03, 2016
FLEX Monoclonal Rabbitt Anti-Human Estrogen Receptor a, Clone EP1, Ready-to-Use (Link)
K160922
Dako North America, Inc.
Pathology · 29d
Cleared Dec 09, 2013
MONOCLONAL MOUSE ANTI-HUMAN PROGESTERONE RECEPTOR, CLONE PGR 636, READY-TO-USE (LINK)
K130861
Dako North America, Inc.
Pathology · 256d
Cleared Nov 16, 2011
CONFIRM ANTI-PROGESTORONE RECEPTOR (1E2) RABBIT MONOCLONAL PRIMARY ANTIBODY
K103818
Ventana Medical Sytems, Inc.
Pathology · 322d
Cleared Jan 29, 2007
VISION BIOSYSTEMS PROGESTERONE RECEPTOR PGR CLONE 16
K062615
Vision Biosystems, Inc.
Pathology · 146d
Cleared Apr 24, 2006
NEOMARKERS RABBIT MONOCLONAL ANTI-HUMAN PROGESTERONE RECEPTOR ANTIBODY (CLONE SP2)
K060462
Lab Vision Corp.
Pathology · 61d
Cleared Feb 15, 2005
DAKOCYTOMATION ER/PR PHARMDX KIT
K042884
Dakocytomation California, Inc.
Pathology · 119d
Cleared Mar 08, 2002
BIOGENEX MONOCLONAL ANTI-PROGESTERONE RECEPTOR
K012960
Biogenex Laboratories
Pathology · 185d
Cleared Feb 28, 2002
DAKO MONOCLONAL MOUSE ANTI-HUMAN PROGESTERONE RECEPTOR, CLONE PGR 636, ANTIBODY FOR IMMUNOENZYMATIC STAINING
K020023
Dako Corp.
Pathology · 56d
Cleared Jul 23, 1999
VENTANA PGR PRIMARY ANTIBODY (CLONE 1A6)
K990618
Ventana Medical Systems, Inc.
Pathology · 148d

About Product Code MXZ - Regulatory Context